PDA News

Author Casts a Spell on Quality Management

by
Robert Darius, GlaxoSmithKline | Mar 30, 2015

Once in a while, a small book can provide great insights, especially when crafted by a 48-year veteran of the medical device industry. I first noticed <strong><a href="http://bookstore.trafford.com/Products/SKU-000145762/The-Making-of-a-Quality-Manager.aspx">Mort Levin’s</a></strong> <a href="http://bookstore.trafford.com/Products/SKU-000145762/The-Making-of-a-Quality-Manager.aspx"><em>The Making of a Quality Manager,</em></a><em> </em>a 100-page book, on Amazon many years ago. I purchased it and stored it at the bottom of my “to-be-read” book stack for several years. It was published by a small vanity publishing house so I did not think it would offer any great learning or insight. But the age-old adage about not judging a book by its cover proved to be very correct in this instance.

Once in a while, a small book can provide great insights, especially when crafted by a 48-year veteran of the medical device industry. I first noticed Mort Levin’sThe Making of a Quality Manager,a 100-page book, on Amazon many years ago. I purchased it and stored it at the bottom of my “to-be-read” book stack for several years. It was published by a small vanity publishing house so I did not think it would offer any great learning or insight. But the age-old adage about not judging a book by its cover proved to be very correct in this instance.

When I finally read this book, I instantly fell under Levin’s spell. Through his humble book and very basic graphics, his spirit and mind were fully open on his thinking of all aspects of Quality. He shared stories of his mistakes and lessons learned in simple and tangible ways. To me, it felt like I was listening to the wisdom of a grandfather or a mentor who had worked through similar challenges in the industry. The guidance in his book helped me verify that what we were trying to achieve was possible—improving the Quality Mindset and driving positive change in a large company across many different sites.

Levin started his career as an engineering manager and was thrust into the role of quality manager in the early 1970s while working in the medical device industry. As an engineer, he was quite sensitive; he stated that “managing quality is much more than numbers. It is about people.”

The goal of perfection in quality is approached asymptotically and never reached. Superiority can only be achieved with vision, commitment and passion from leaders at all levels within the organization.

“A quality manager is not able to help their company by staying in the quality department only. They must understand how the other departments function. They must understand the processes as well or even better, than most members of the company,” Levin wrote.

I believe Quality has reached an ideal state when they can out think production and validation teams, knowing the process so well that multiple solutions or designs of experiments to prove a hypothesis emerge. Importantly, individuals working in Quality must work diligently to not give answers to their teams but instead steer team members to help reach the answers themselves.

The author urged readers to remember to pay attention. Dig. Learn the fundamentals. Analyze. Work to high standards. Remember that details are important. How many of us have the time, or make the time, to live by these points now that we drown in information on the internet and our mailboxes overflow with hundreds of emails each day? Implementing these points alone could avoid many challenges in the industry.

Levin offered the following ten points for Quality success:

Acknowledge that everyone wants to do a good job. They just need the appropriate training, tools, the right environment and leaders.

Auditing is not the best way of assuring safe and effective products. The system must be in control at all times.

Reliability, reliability, reliability!

A standard or regulation is not a substitute for a quality system.

A quality manager should be as interested in profit as any other manager. Do your best to help make a real product, one that meets cost and profit objectives.

Quality is too important to be left solely in the hands of the quality manager. Everyone has a part in providing the proper quality.

Wander around the factory and the field. Listen, learn and communicate.

Do not be quick to blame the worker. There is likely a manager or supervisor who might be the cause of the problem.

Levin dedicated his book to all those who did the real work in improving Quality and to those who helped him become a quality manager. His book inspired me so much that I purchased copies to share with my team and other peers.

In his book, Levin wrote about the giants in his career, people who helped others by sharing their wisdom, knowledge and experiences—ultimately allowing others to climb on their shoulders and take advantage of what they have done, giving others a view of the future and how they should reach their goals. I would say that Levin is a giant and I appreciate being able to stand on his shoulders after reading and reflecting on his little book, The Making of a Quality Manager. Thank you, Mort Levin.

About the Reviewer

Robert Darius is Vice President of the Regional Quality Unit for GlaxoSmithKline Vaccine’s four manufacturing sites located in Germany and North America.